CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.
| Condition(s) | Patients With Resected Stage II Colon Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA. |
| Who can participate | Inclusion Criteria: * Signed written informed consent obtained prior to any study specific procedures * Age ≥ 18 years and ≤ 75 years * Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent. Pathology report must be faxed to CRGA just after patient's randomization. * At least 12 lymph nodes analyzed * Patient with MSI + tumors can be included * All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy * No metastatic disease on CT-Scan and/or liver MRI |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Centre Hospitalier Universitaire Dijon |
| Locations | Dijon, France |
| Start date | 2020-01-17 |
| NCT ID | NCT04120701 |
| Official listing | https://clinicaltrials.gov/study/NCT04120701 |